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The one Q&A in this section focuses on the meaning of significant increase in clinical dose of marketed products.

The relevant section in the guideline (4.3 Changes to the Clinical Use of Marketed Products) states the following (with emphasis on the critical phrase): “Changes to the clinical use of marketed products that can warrant a reevaluation of the mutagenic impurity limits include a significant increase in clinical dose, an increase in duration of use (in particular when a mutagenic impurity was controlled above the lifetime acceptable intake for a previous indication that may no longer be appropriate for the longer treatment duration associated with the new indication), or for a change in indication from a serious or life threatening condition where higher acceptable intakes were justified (Section 7.5) to an indication for a less serious condition where the existing impurity acceptable intakes may no longer be appropriate.”